Diabetes Prevention Tips

According to statistics by the WHO, “The number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014.” Also, “In 2016, an estimated 1.6 million deaths were directly caused by diabetes. Another 2.2 million deaths were attributable to high blood glucose in 2012.” It is astounding how many people…

Biosimilars: Advantages & Challenges

Introduction A biosimilar product, as defined by USFDA, is “a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.” By 2020, the biosimilar market is expected to reach $15 billion booming market, which is thrice the presentmarket(Ragunadhan 2018).Latest additions to this category of drugs are…

EU IVDR 2017/746: Overview of Regulation Changes

The In Vitro medical devices faced the implementation of the European Community Directive 98/79/EC in 1998. The In Vitro Diagnostic Directive (IVDD) 98/79/EC has been now transformed to In Vitro Diagnostic Regulation (IVDR) 2017/746/EU. The official timeline for this transition phase to complete implementation is 5 years (26th May 2022). The current regulatory framework for…

INNOVATIONS IN PEER-REVIEW

Peer Review is the process of evaluation of manuscripts submitted for scientific publication in journals/books, pre-clinical or clinical study reports, research progress reports etc., by experts or peers with similar competence as manuscript authors. It plays a pivotal role in scholarly publications with objective to ascertain quality, reliability and credibility of the work reported in…

Moving to Virtual Clinical Trials

In the clinical trials industry, 80% of trials do not meet enrolment timelines, leading to a loss of $8 million per day. Delayed enrolment not only impacts trial timelines, but more trials are being cancelled because of it, preventing investigators from determining the safety and efficacy of what could be promising new therapies for patients…